Three Cancellous Screws Versus Four Cancellous Screws for Femoral Neck Fixation

April 30, 2021 updated by: Peking University Third Hospital

A Prospective Randomised Controlled Clinical Trial: Three Cancellous Screws Versus Four Cancellous Screws for Fixation of Femoral Neck Fractures

This study is a prospective randomized controlled clinical study. Patients with femoral neck fracture (AO classification 31-B) will be randomly divided into three-screw fixation group and four-screw fixation group. The internal fixation failure rate (IFFR) and functional outcomes of the two groups will be compared and the patients will be followed up to 2 years after surgery.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is a prospective randomized controlled clinical trial. All patients will be randomly divided into 2 groups at a ratio of 1:1. The investigators will use three screws for internal fixation in the first group, and four screws for internal fixation in the second group. The relevant parameters of the sample calculation are α = 0.05 (one-sided) and β = 0.2. PASS 15 was used for calculation, and the final sample size was 290, 145 for each group. Subjects who meet all the inclusion conditions but do not meet any exclusion conditions and have signed the informed consent will be randomized, and each patient will be assigned a unique patient identification number, which will be used throughout the study. Using a computer random allocation system, eligible patients were randomly divided into the two groups at a ratio of 1:1. The investigators will perform preoperative preparations, intraoperative operations, and internal fixation in accordance with the instructions provided in the internal plant product packaging. The investigators only plan to include cases in which closed reduction can be successfully performed, so the investigators will exclude cases that require open reduction. For the three-screw group, three cancellous screws with an inverted triangle pattern are used to fix the fracture of femoral neck. For the four-screw group, the fourth screw will be implanted in the horizontal direction of the femoral distance on the basis of the three screws. After the operation, the subjects will be managed according to the standard nursing and rehabilitation procedures at the experimental site and the results of laboratory examinations will be recorded. Regular follow-up evaluations will be carried out after the operation until the end of the two-year follow-up or the end of the study. In this study, the internal fixation failure rate (IFFR) will be used as the main research endpoint, which is defined as the total incidence of cutouts, fractures. The results of the radiographic examination, the lateral X-ray film and computed tomography(CT), will be evaluated by an independent radiologist to determine whether there are cut-out or fracture of the internal plant. Secondary endpoints include: 1. Bone nonunion after 36 weeks: evaluate bone healing according to the lateral X-ray examination. According to the regulations of Food and Drug Administration of the US, it is defined as nonunion if there are no obvious signs of fracture healing 9 months after the fracture, or if there is no obvious difference in fracture space after three consecutive months. 2. Garden classification proportion, and Garden index for reduction assessment. 3. Clinical prognosis: o A 12-Item Short-Form Health Survey (SF-12) o Harris hip score. 4. Operation time, from the incision to internal fixation implanted. 5. The times of intraoperative fluoroscopy, average 25 milliseconds per X-ray shot, record the number of X-ray shot. 6. Postoperative adverse events within 2 years, including ipsilateral femoral head avascular necrosis, infection, wound hematoma, ipsilateral coxa vara, and ipsilateral limb shortening. In this study, it is difficult to blind anyone to randomization. However, considering that most of the patients may not have medical expertise, if the researchers do not inform them, the patients are the only people who may be blind. Investigators will try their best to reduce human-induced bias in experimental results. Investigators will use one-sided α = 0.05 for statistical tests and confidence interval calculations. P value <0.05 is considered statistically significant. SPSS (latest version: SPSS Inc., Chicago, IL, USA) will be used to analyze the results.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
290

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100191
        • Recruiting
        • Peking University Third Hospital
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age ≥18 years
  • Patients with unilateral femoral neck fractures that will be treated with internal fixation
  • According to AO fracture classification, subjects with the fracture type (31-B)
  • Subjects (with the help of relatives) can understand the informed documents and patient questionnaires.
  • Subjects (with the help of relatives) voluntarily provide written informed consent to participate in the clinical study and authorize the transfer of their information to the sponsor.
  • The investigator believes that the subject can understand the clinical study, is willing and able to complete all research procedures and follow-up visits and can cooperate with the research procedures.
  • In-label use of the MCS.

Exclusion Criteria:

  • Subject does not provide voluntary consent to participate in the study.
  • The researcher believes that the subjects have conditions that affect the participation and follow-up of this study. (for example, the patient lives in a remote area or has difficulty in going back to the hospital for follow-up or does not cooperate with the medical guidance and suggestions of the surgeon.)
  • The subjects were pregnant or lactating women.
  • The researchers believe that the subjects have psychological disorders, which may affect the treatment outcome.
  • Garden classification III and IV of femoral neck fracture patients older than 65 years
  • Concurrent hip osteoarthritis.
  • Fractures where the operative treatment will occur more than three weeks after the primary injury
  • Patients combined with femoral head fractures(31-C), femoral shaft fractures(32-A/B/C) or femoral trochanteric area fracture (31-A1/A2/A3).
  • Pathological fracture (e.g., primary or metastatic tumor)
  • Serious soft tissue injury, judged by the investigator, will impact the union of the fracture, combined vascular injury, and combined osteofascial compartment syndrome
  • Multiple systemic injuries judged by researchers not suitable for enrollment.
  • Revision surgeries (for example, due to malunion, nonunion or infection)
  • Concurrent medical conditions judged by researchers not suitable for enrollment, such as: metabolic bone disease, post-polio syndrome, poor bone quality, prior history of poor fracture healing, etc
  • Patients with anaesthetic and surgical contraindications
  • Patients known to be allergic to implant components
  • Patients who are currently using chemotherapeutics or accepting radiotherapy, use systematically corticosteroid hormone or growth factor, or long-term use sedative hypnotics (continuous use over 3 months) or non-steroidal anti-inflammatory drugs (continuous use over 3 months)
  • Intemperance judged by researchers not suitable for enrollment (e.g., excessive daily drinking or smoking, drug abuse);
  • Subjects participated in other clinical studies in the past 3 months, which may affect the outcome and follow-up according to the judgment of researchers.
  • Subjects have significant neurological or musculoskeletal disorders or may have adverse effects on gait or weight-bearing (e.g., muscular dystrophy, multiple sclerosis, cerebral infarction, hemiplegia, Charcot arthropathy, avascular necrosis of the femoral head).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: three-screw group
three cancellous screws with an inverted triangle pattern are used to fix the fracture of femoral neck
Device: three cancellous screws
All patients with femoral neck fractures will be randomly divided into 2 groups at a ratio of 1:1. Three screws for internal fixation in the three-screw group, and three cancellous screws with an inverted triangle pattern are used to fix the fracture of femoral neck.
Experimental: four-screw group
the fourth screw will be implanted in the horizontal direction of the femoral distance on the basis of the three screws.
Device: four cancellous screws
All patients with femoral neck fractures will be randomly divided into 2 groups at a ratio of 1:1. Four screws for internal fixation in the four-screw group, and the fourth screw will be implanted in the horizontal direction of the femoral distance on the basis of the three screws.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Internal fixation failure rate
Time Frame: from operation to 2-year follow-up after the surgery
defined as the total incidence of internal plant cut-out and fracture
from operation to 2-year follow-up after the surgery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Harris hip score
Time Frame: from operation to 2-year follow-up after the surgery
the score value is from 0 to 100, and a higher score means a better outcome
from operation to 2-year follow-up after the surgery
operation time
Time Frame: intraoperative
from the incision to internal fixation implanted.
intraoperative
The times of intraoperative fluoroscopy
Time Frame: intraoperative
average 25 milliseconds per X-ray shot, record the number of X-ray shot
intraoperative
Garden index
Time Frame: from operation to 2-year follow-up after the surgery
The fracture reduction will be considered unsatisfied if the index is less than 155 degrees or more than 180 degrees.
from operation to 2-year follow-up after the surgery
Number of Participants with Bone nonunion
Time Frame: from operation to 9-month follow-up after the surgery
evaluate bone healing according to the lateral X-ray examination. According to the regulations of Food and Drug Administration of the US, if there are no obvious signs of fracture healing 9 months after the fracture, or if there is no obvious difference in fracture space after three consecutive months, it is defined as nonunion.
from operation to 9-month follow-up after the surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Peking University Third Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Fang Zhou, M.D., Peking University Third Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 8, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2026

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 9, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 30, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 3, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 3, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 30, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PekingUTH LY MCS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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